Complication of Surgical ProcedureNCT06482866
Synechie Afrer Rhinosug. Proc. 2024
An observational study of Complication of Surgical Procedure, run by Mateusz Jan Stępiński at 1 site in Poland.
Trial summary
Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future. Analyze of the medical documentation. It was not an experimental examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- Cottle's septoplasty and radiocoagulation conchoplasty
- How many people
- 243 participants
- Where
- 1 sitePoland
- Study dates
- 26 Jun 2024to 26 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who were operated in Polish hospital (Gorzów Wlkp).
Who may be able to join
- septo or septoconchoplasty
Who cannot join
- incompleted documentation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Multidisciplinary Regional Hospital
Gorzów Wielkopolski, Woj. Lubuskie, 66-400
About this study
Official title: Risk Factors Leading to the Formation of Intranasal Synechiae in Patients After Endonasal Surgery
Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future.
Analyze of the medical documentation. It was not an experimental examination.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Cottle's septoplasty and radiocoagulation conchoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cottle's septoplasty and radiocoagulation conchoplastyOther
Cottle's septoplasty and radiocoagulation conchoplasty Study group - added nasal splits; Control group - nasal splits weren't used.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients underwent septoconchoplasty with or without turbionplasty. Surgeons didn't use nasal splits. Receives: Other: Cottle's septoplasty and radiocoagulation conchoplasty | |
| Study group | Patients underwent septoconchoplasty with or without turbionplasty. Surgeons used nasal splits. Receives: Other: Cottle's septoplasty and radiocoagulation conchoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synechie
Intranasal synechiae after rhino nasal procedures
Measured: Between 2 weeks to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start26 Jun 2024
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateusz Jan Stępiński
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mateusz Jan Stępiński, Multidisciplinary Regional Hospital in Gorzow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482866
- Sponsor's protocol ID
- SYNECHIE2024
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication of results in open access magazine
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Leading to the Formation of Intranasal Synechiae in Patients After Endonasal Surgery
- ClinicalTrials.gov ID
- NCT06482866
- Acronym / sponsor ID
- SYNECHIE2024
- Conditions
- Complication of Surgical Procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Mateusz Jan StępińskiUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future.
Analyze of the medical documentation. It was not an experimental examination.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Cottle's septoplasty and radiocoagulation conchoplastyPatients underwent septoconchoplasty with or without turbionplasty. Surgeons didn't use nasal splits. |
| Study group | – | Other: Cottle's septoplasty and radiocoagulation conchoplastyPatients underwent septoconchoplasty with or without turbionplasty. Surgeons used nasal splits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who were operated in Polish hospital (Gorzów Wlkp).
Key inclusion criteria (1 listed)
- septo or septoconchoplasty
Key exclusion criteria (1 listed)
- incompleted documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cottle's septoplasty and radiocoagulation conchoplastyCottle's septoplasty and radiocoagulation conchoplasty Study group - added nasal splits; Control group - nasal splits weren't used. | Other | Control group, Study group |
Primary outcome
Synechie
Time frame: Between 2 weeks to 12 month
Intranasal synechiae after rhino nasal procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Undecided. Publication of results in open access magazine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Surgical Procedure, run by Mateusz Jan Stępiński at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synechie (time frame: Between 2 weeks to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024; AzTrials last refreshed its copy on 29 Oct 2026.